Acute and Longlasting Side Effects Caused by Radiotherapy in the Head and Neck Area

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
St. Olavs Hospital
Helse Midt-Norge
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00995319
First received: October 14, 2009
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

The purpose of this clinical investigation is to evaluate acute and longlasting side effects in patients undergoing radiotherapy for cancer treatment in the head and neck area.


Condition
Head and Neck Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acute and Longlasting Side Effects Caused by Radiotherapy in the Head and Neck Area

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • salivary flow [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • salivary flow [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: January 2008
Estimated Study Completion Date: December 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
radiation patients
cancer patients with radiotherapy concerning the head and neck area/oral cavity

Detailed Description:

The "Dental Team" at the Department for Oral and Maxillofacial Surgery in Trondheim takes care of patients before, during and also after radiotherapy in the head and neck area. In spite of the use of advanced radiation protocols and prevention measures such as fluoridation splints the team observes significant side effects, both under radiation and also on the long term after concluding treatment. Common problems are for example dermal and mucosal damages, reduced salivation, dysphagia and lesions of the teeth. Aim of the study is the investigation and documentation of side effects and complications in relation to the oral cavity. During the acute and postradiation phase a continuous follow-up over a longer lasting period is proceeded with registration of all relevant parameters. This includes among others dental status and evaluation of quality of life.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All cancer patients with radiation therapy concerning the oral cavity who are in care of the Detal Team at St.Olavs University Hospital

Criteria

Inclusion Criteria:

  • radiation concerning the oral cavity
  • follow-up at the Dental Team

Exclusion Criteria:

  • refused approval
  • survival prognosis under one year
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00995319

Locations
Norway
Department for Oral and Maxillofacial Surgery, St.Olavs Hospital / NTNU
Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Helse Midt-Norge
Investigators
Study Director: Christoph M Ziegler, Prof.Dr.Dr. St.Olavs Hospital / NTNU
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00995319     History of Changes
Other Study ID Numbers: 17436
Study First Received: October 14, 2009
Last Updated: July 29, 2013
Health Authority: Norway: Directorate of Health
Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
mouth
Mucositis
Dysphagia
malnutrition
Xerostomia
saliva
tooth injuries

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on April 15, 2014